Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

A Phase 3b, Randomized, Open-Label Assessment of Response to Various Doses of Atomoxetine Hydrochloride in Korean Pediatric Outpatients With Attention-Deficit/Hyperactivity Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00568685
• Other study ID #: 11710
• Secondary ID: B4Z-KL-LYEC
• Status: Completed
• Phase: Phase 3
• First received: December 4, 2007
• Last updated: January 19, 2010
• Start date: November 2007
• Est. completion date: November 2008

Study information

• Verified date: January 2010
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to provide information regarding the relative effectiveness of three different atomoxetine doses in the treatment of Korean children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• Patients will be outpatients who are aged 6 to 18 years old at the initial screening visit.

• Patients must have ADHD, based on the accepted criteria for that disease

• Patients must not have taken any medication used to treat ADHD for at least two weeks prior to beginning study treatment; and at least one week prior to the study screening visit during which initial ADHD assessments were made

• Patients must be able to swallow capsules

• Patients and parents (or legal guardians) must be judged by the study investigator to be reliable to keep appointments for clinic visits and all tests, including blood tests and any other required examinations

Exclusion Criteria:

• Patients must not have received any treatment within the last 30 days with a drug that has not been approved by their country's appropriate government agency

• Patients will not be included in the study if they have previously experienced any unwanted effects or serious medical events during atomoxetine treatment

• Patients will not be included in the study if they are judged by the study investigator to be at serious suicidal risk

• Patients will not be included in the study if they have cardiovascular disease or other conditions that could be worsened by an increased heart rate or increased blood pressure

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Atomoxetine Hydrochloride
Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period
• Atomoxetine hydrochloride
Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period
• Atomoxetine hydrochloride
Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days

Locations

Country	Name	City	State
Korea, Republic of	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bucheon
Korea, Republic of	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	In Cheon
Korea, Republic of	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Day 42 Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score		Baseline, Day 42	No
Secondary	Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint		Baseline, Days 7, 14, 42	No
Secondary	Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint		Baseline, Days 7, 14, 42	No
Secondary	Adverse Events Leading to Discontinuation		Baseline to Day 42	Yes
Secondary	Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary		Baseline to Day 42	Yes
Secondary	Heart Rate Change From Baseline to Day 42 Endpoint		Baseline, Day 42	No
Secondary	Temperature Change From Baseline to Day 42 Endpoint		Baseline, Day 42	No
Secondary	Blood Pressure Change From Baseline to Day 42 Endpoint		Baseline, Day 42	No
Secondary	Weight Change From Baseline to Day 42 Endpoint		Baseline, Day 42	No

External Links

•   Lilly Clinical Trial Registry